title: Progress in biological threat agent vaccine development: a repeat-dose toxicity study of a recombinant ricin toxin A-chain (rRTA) 1-33/44-198 vaccine (RVEc) in male and female New Zealand white rabbits.
abstract: A recombinant ricin toxin A-chain 1-33/44-198 vaccine (RVEc) was administered to male and female New Zealand white (NZW) rabbits (10/sex/group) in a repeat-dose toxicity study. The RVEc vaccine was administered on study days 1, 29, 57, and 85 via intramuscular (IM) injection (0, 100, or 200 μg/dose). All study animals were observed throughout treatment until euthanized and submitted for necropsy on study day 88 or 99 (recovery period). There were no treatment-related or toxicologically significant effects observed. There were no statistically significant differences noted in the antibody titers and/or concentrations in 100 μg RVEc-treated animals when compared to 200 μg RVEc-treated animals, suggesting that both doses produced comparable antibody titers/concentrations during the study. The highest immune response was observed on study day 99 (ie, 2 weeks after the last dose). The immune response observed demonstrated that RVEc is biologically active in the rabbit model, with no apparent marked sex differences.
authors.affiliation: Walker Downey & Associates, Inc, Verona, WI, USA.
authors.forename: Daniel E
authors.initials: DE
authors.lastname: McLain
authors.forename: Thomas L
authors.initials: TL
authors.lastname: Horn
authors.forename: Carol J
authors.initials: CJ
authors.lastname: Detrisac
authors.forename: Changhong Y
authors.initials: CY
authors.lastname: Lindsey
authors.forename: Leonard A
authors.initials: LA
authors.lastname: Smith
mesh_terms: D000818:Animals; D057134:Antibodies, Neutralizing / Q000097:blood; D001688:Biological Products; D054045:Biological Warfare Agents; D004306:Dose-Response Relationship, Immunologic; D004353:Drug Evaluation, Preclinical; D004926:Escherichia coli / Q000235:genetics / Q000378:metabolism; D005260:Female; D007074:Immunoglobulin G / Q000097:blood; D008297:Male; D023421:Models, Animal; D019055:No-Observed-Adverse-Effect Level; D011817:Rabbits; D012276:Ricin / Q000008:administration & dosage* / Q000276:immunology / Q000633:toxicity*; D014614:Vaccines, Synthetic / Q000008:administration & dosage* / Q000276:immunology
chemical_list: D057134:Antibodies, Neutralizing; D001688:Biological Products; D054045:Biological Warfare Agents; D007074:Immunoglobulin G; D014614:Vaccines, Synthetic; D012276:Ricin